Collecting high-quality biomaterial from patients with neurodegenerative diseases and controls for diagnostic and prognostic biomarker investigation/validation, therapeutic applications and other research activities

Investigation of novel biomarkers and therapeutics in neurodegenerative diseases

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10684984

Enrollment

200

Registered

2025-11-03

Start date

2025-08-01

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assessment of early biomarkers that predict disease progression and help identifying novel therapeutic options for patients with Alzheimer's Disease (AD) and Parkinson's Disease (PD). Nervous System Diseases

Interventions

Participants will meet face-to-face with a researcher for this study. They will have received the PIS in advance and will have an opportunity to go through any questions before they sign the consent f

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Signed informed consent form 2. Adults of any gender, ethnicity or socio-economic group, with any of the mentioned conditions, aged 18 years and above 3. Participants who can provide informed consent for taking blood and/or urine as required 4. Participants who can have a blood and/or urine sample taken 5. Participants who have an established diagnosis of the mentioned neurodegenerative conditions 6. First-degree relatives (parents, siblings, children) of patients with any of the mentioned conditions 7. Partners/carers and other healthy control volunteers

Exclusion criteria

Exclusion criteria: 1. Participants who are currently involved in interventional clinical trials 2. Participants with severe intellectual impairment, who would be unable to cooperate and consent

Design outcomes

Primary

Measure	Time frame
Extracellular vesicles (EVs) will be isolated from the serum samples, and their molecular contents will be analyzed using quantitative liquid chromatography–mass spectrometry (LC-MS). The mass spectrometry data—reflecting the expression levels of biological particles contained within the EVs—will undergo statistical evaluation and be processed by a custom-built artificial intelligence (AI) model designed to differentiate between patients and healthy controls. The study cohort will consist of treatment-naïve individuals at baseline and patients who have initiated treatment at either the 6- or 12-month time points. The study is planned to last 3 years, comprising a 9-month enrolment period followed by a 6-month follow-up for each participant.	—

Measure

Time frame

Extracellular vesicles (EVs) will be isolated from the serum samples, and their molecular contents will be analyzed using quantitative liquid chromatography–mass spectrometry (LC-MS). The mass spectrometry data—reflecting the expression levels of biological particles contained within the EVs—will undergo statistical evaluation and be processed by a custom-built artificial intelligence (AI) model designed to differentiate between patients and healthy controls. The study cohort will consist of treatment-naïve individuals at baseline and patients who have initiated treatment at either the 6- or 12-month time points. The study is planned to last 3 years, comprising a 9-month enrolment period followed by a 6-month follow-up for each participant.

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Contacts

Public ContactChloe Walsh

research@sabp.nhs.uk+44 (0)1372 216584

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026